The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Xuanwu Hospital Beijing,Capital Medical University
Beijing, Beijing Municipality, China
The peak plasma concentration (Cmax) of SHR0302.
Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302.
Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The relative bioavailability of SHR0302 tablets with 3 different formulations.
The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time.
Time frame: through study completion, an average of 1 month.
The Peak Time (Tmax) of SHR0302.
Based on the SHR0302 plasma concentration data set, calculate the time to reach peak plasma concentration of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The Elimination half-life (T1/2) of SHR0302.
Based on the SHR0302 plasma concentration data set, calculate the time required for the blood concentration of SHR0302 to drop by half.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The Clearance (CL/F) of SHR0302.
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Group D subjects were given oral F2 、F3 and F1 version SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302
Based on the SHR0302 plasma concentration data set, calculate the clearance of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The apparent volume of distribution (Vz/F) of SHR0302.
Based on the SHR0302 plasma concentration data set, calculate the apparent volume of distribution of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Incidence of adverse events.
laboratory abnormalities (based on hematology, biochemistry, coagulation function, and urinalysis tests), vital sign measurements (include blood pressure, pulse rate, respiratory rate, and body temperature) and 12-Lead electrocardiogram.
Time frame: through study completion, an average of 1 month